Fluid seals for catheter pump motor assembly

ABSTRACT

A catheter pump system is disclosed. The catheter pump system can include a shaft assembly and an impeller coupled with a distal portion of the shaft assembly. A motor assembly can impart rotation on the impeller through the shaft assembly, the motor assembly comprising a motor which rotates the shaft assembly. The catheter pump system can include a fluid pathway which conveys fluid proximally during operation of the catheter pump system. A seal can be disposed between the motor assembly and the impeller. The seal can be configured to impede or prevent the fluid from the fluid pathway from entering the motor assembly at least about an outer periphery of the shaft assembly. The seal can comprise an opening through which a portion of the shaft assembly extends.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims the benefit of U.S.patent application Ser. No. 15/654,402, filed Jul. 19, 2017, whichclaims the benefit of and priority to U.S. Provisional PatentApplication No. 62/365,215, filed Jul. 21, 2016, the contents of each ofwhich are hereby incorporated by reference herein in their entirety.

BACKGROUND Field of Invention

This application is directed to catheter pumps for mechanicalcirculatory support of a heart.

Description of the Related Art

Heart disease is a major health problem that has high mortality rate.Physicians increasingly use mechanical circulatory support systems fortreating heart failure. The treatment of acute heart failure requires adevice that can provide support to the patient quickly. Physiciansdesire treatment options that can be deployed quickly andminimally-invasively.

Mechanical circulatory support (MCS) systems and ventricular assistdevices (VADs) have gained greater acceptance for the treatment of acuteheart failure such as acute myocardial infarction (MI) or to support apatient during high risk percutaneous coronary intervention (PCI). Anexample of an MCS system is a rotary blood pump placed percutaneously,e.g., via a catheter.

In a conventional approach, a blood pump is inserted into the body andconnected to the cardiovascular system, for example, to the leftventricle and the ascending aorta to assist the pumping function of theheart. Other known applications include placing the pump in thedescending aorta, a peripheral artery, and the like. Typically, acutecirculatory support devices are used to reduce the afterload on theheart muscle and provide blood flow for a period of time to stabilizethe patient prior to heart transplant or for continuing support.

There is a need for improved mechanical circulatory support devices fortreating acute heart failure. There is a need for minimally-invasivedevices designed to provide near full heart flow rate.

There is a need for a blood pump with improved performance and clinicaloutcomes. There is a need for a pump that can provide elevated flowrates with reduced risk of hemolysis and thrombosis. There is a need fora pump that can be inserted minimally-invasively and provide sufficientflow rates for various indications while reducing the risk of majoradverse events.

In one aspect, there is a need for a heart pump that can be placedminimally-invasively, for example, through an 18 FR, 14 FR, or 8 FRincision. In one aspect, there is a need for a heart pump that canprovide an average flow rate of 4 Lpm or more during operation, forexample, at 62 mmHg of aortic pressure.

While the flow rate of a rotary blood pump can be increased by rotatingthe impeller faster, higher rotational speeds are known to increase therisk of hemolysis, which can lead to adverse outcomes and in some casesdeath. Higher speeds also lead to performance and patient comfortchallenges. Many percutaneous ventricular assist devices (VADs) havedriveshafts between the motor and impeller rotating at high speeds. Somepercutaneous VADs are designed to rotate at speeds of more than 15,000RPM, and in some cases more than 25,000 RPM in operation. The vibration,noise, and heat from the motor and driveshaft can cause discomfort tothe patient, especially when positioned inside the body. Moreover,fluids (such as saline and/or blood) may enter the motor, which candamage the motor and/or impair operation of the catheter pump.Accordingly, there is a need for a device that improves performance andpatient comfort with a high speed motor.

There is a need for a motor configured to drive an operative device,e.g., an impeller, atherectomy device, or other rotating feature Thereis a need for an improved motor with sealing between each end. There isa need for a motor capable of rotating at relatively high speeds andproviding sealing between a wet side and an electrical side.

These and other problems are overcome by the inventions describedherein.

SUMMARY

There is a need for a pumping device that can be inserted percutaneouslyand also provide full cardiac rate flows of the left, right, or both theleft and right sides of the heart when called for.

In one embodiment, a catheter pump system is disclosed. The catheterpump system can include a shaft assembly and an impeller coupled with adistal portion of the shaft assembly. The catheter pump system caninclude a motor assembly comprising a motor configured to impartrotation to the impeller through the shaft assembly. The catheter pumpsystem can include a fluid pathway for supplying a fluid from outsidethe body, the fluid pathway conveying at least a portion of the suppliedfluid proximally during operation of the catheter pump system. Thecatheter pump system can include a seal disposed between the motorassembly and the impeller, the seal configured to impede the fluidconveyed proximally in the fluid pathway by the impeller from enteringthe motor assembly at least about an outer periphery of the shaftassembly, the seal comprising an opening through which a portion of theshaft assembly extends.

In some embodiments, the shaft assembly comprises an output shaftcoupled with the motor and a drive shaft coupled with the impeller, adistal portion of the output shaft coupled with a proximal portion ofthe drive shaft. A motor coupling can mechanically connect the proximalportion of the drive shaft with the distal portion of the output shaft.The motor coupling can comprise an opening having at least one flatsurface, wherein at least one of the output shaft and the drive shaft isfitted in the opening. A second seal can be disposed between the motorassembly and the impeller, the second seal configured to further impedeor prevent the fluid conveyed proximally in the fluid pathway fromentering the motor assembly at least about the outer periphery of theshaft assembly. A barrier can separate the motor assembly from amajority of the proximally-conveyed fluid, wherein the seal is disposeddistal and adjacent the barrier, and wherein the second seal is disposedproximal and adjacent the barrier. The barrier can comprise a proximalportion of a flow diverter housing through which the proximally-conveyedfluid flows. The shaft assembly can comprise a lumen therethrough, thelumen passing through the motor. The lumen can pass through the catheterpump system from a distal end of the catheter pump system to a proximalend of the catheter pump system. The lumen can comprise a portion of thefluid pathway such that at least some of the fluid passes through thelumen. The catheter pump system can include a guidewire guide tubedisposed in the lumen, the guidewire guide tube configured to receive aguidewire therein for guiding the impeller to a target site of apatient. In some embodiments, the shaft assembly extends through atleast a portion of the motor, through the opening of the seal, and tothe impeller. In some embodiments, the motor can comprise a direct driveelectric motor, e.g., a motor without any gear reduction and/or aclutch. The motor can comprise a rotor and a stator assembly disposedabout the rotor. The rotor can be disposed in a chamber, and wherein theseal prevents or impedes the proximally-flowing fluid from entering thechamber. The catheter pump system can include an insulating coating overthe shaft assembly to electrically separate the shaft assembly from apatient. The seal can comprise a lip seal disposed about the shaftassembly, the lip seal biased radially inward to bear against the outerperiphery of the shaft assembly. In some embodiments, the seal comprisesa flange which converts axial fluid pressure to radially inward pressureto further bear against the outer periphery of the shaft assembly. Insome embodiments, the catheter pump system can include a chamber, theseal disposed in the chamber, the chamber defining a portion of thefluid pathway. A catheter assembly can be disposed between the motorassembly and the impeller, the catheter assembly defining at least aportion of the fluid pathway. The fluid pathway can comprise a firstchannel configured to permit the supplied fluid to flow from proximallyto distally in the catheter assembly and a second channel that conveysthe at least a portion of the supplied fluid proximally along the shaftassembly. The catheter pump system can include a cannula in which theimpeller is disposed, the cannula and impeller expandable from a storedconfiguration to a deployed configuration.

In one embodiment, a catheter pump system is disclosed. The catheterpump system can include a shaft assembly and an impeller coupled with adistal portion of the shaft assembly. The catheter pump system caninclude a motor assembly that imparts rotation on the impeller throughthe shaft assembly, the motor assembly comprising a motor that rotatesthe shaft assembly, the shaft assembly comprising an output shaftportion through the motor, the output shaft portion comprising a motorlumen. The catheter pump system can include a fluid pathway forsupplying a fluid from outside the body, the fluid pathway conveying atleast a portion of the supplied fluid proximally during operation of thecatheter pump system. The catheter pump system can include a sealdisposed between the motor assembly and the impeller, the sealconfigured to impede or prevent the fluid from the fluid pathway fromentering the motor assembly at least about an outer periphery of theshaft assembly.

In some embodiments, the seal comprises an opening through which aportion of the shaft assembly extends. The shaft assembly can furthercomprise a drive shaft portion coupled with the impeller, a distalportion of the output shaft portion coupled with a proximal portion ofthe drive shaft portion. The shaft assembly can comprise a guidewireguide lumen therethrough, the guidewire guide lumen comprising the motorlumen, wherein the guidewire guide lumen passes through the catheterpump system from a distal end of the catheter pump system to a proximalend of the catheter pump system. The lumen can define a portion of thefluid pathway such that at least some of the fluid passes through thelumen. The catheter pump system can include a guidewire guide tubedisposed in the lumen, the guidewire guide tube configured to receive aguidewire therein for guiding the impeller to a target site of apatient. In some embodiments, a second seal can be disposed between themotor assembly and the impeller, the second seal configured to furtherimpede or prevent the fluid from the fluid pathway from entering themotor assembly at least about the outer periphery of the shaft assembly.A barrier can separate the motor assembly from a majority of theproximally-conveyed fluid, wherein the seal is disposed distal andadjacent the barrier, and wherein the second seal can be disposedproximal and adjacent the barrier. An insulating coating can be disposedover the shaft assembly to electrically separate the shaft assembly froma patient. The seal can comprise a lip seal disposed about the shaftassembly, the lip seal biased radially inward to bear against the outerperiphery of the shaft assembly. The seal can comprise a flange whichconverts axial fluid pressure to radially inward pressure to furtherbear against the outer periphery of the shaft assembly. The catheterpump system can include a flow diverter comprising a chamber, the sealdisposed in the chamber, the chamber defining a portion of the fluidpathway. A first channel can be configured to permit fluid to flow fromproximally to distally in the catheter pump system and a second channelcan convey the at least a portion of the supplied fluid proximally.

In one embodiment, a method of operating a pump is disclosed, the pumpcomprising an impeller and a motor assembly comprising a motor coupledwith the impeller. The method can include rotating a shaft assembly withthe motor to impart rotation to the impeller. The method can includedirecting fluid into the pump from outside the body, at least a portionof the fluid flowing back proximally along a fluid pathway between theimpeller and the motor assembly. The method can include impeding thefluid from entering the motor assembly at least about an outer peripheryof the shaft assembly with a seal, the seal comprising an openingthrough which a portion of the shaft assembly extends.

In some embodiments, the method can include directing at least some ofthe fluid through a lumen extending through an output shaft portion ofthe shaft assembly, the output shaft portion passing through the motor.The method can include inserting a guidewire through the lumen, andadvancing the pump over the guidewire to a target site in a patient. Themethod can include expanding the impeller from a stored configuration toa deployed configuration.

In one embodiment, a catheter pump system is disclosed. The catheterpump system can include a shaft assembly and an impeller coupled with adistal portion of the shaft assembly. The catheter pump system caninclude a motor assembly that imparts rotation on the impeller throughthe shaft assembly, the motor assembly comprising a motor that rotatesthe shaft assembly, the shaft assembly comprising an output shaftportion through the motor, the output shaft portion comprising a motorlumen. The catheter pump system can include a fluid pathway that conveysfluid proximally during operation of the catheter pump system, the fluidpathway comprising a first fluid pathway comprising a conduit thatdirects a first portion of the fluid to bypass the motor assembly and asecond fluid pathway that directs a second portion of the fluid throughthe motor lumen, the conduit connecting with the fluid pathway at aposition distal the motor assembly. The catheter pump system can includea seal disposed between the motor assembly and the position, the sealconfigured to impede or prevent the fluid from the fluid pathway fromentering the motor assembly at least about an outer periphery of theshaft assembly, the seal comprising an opening through which a portionof the shaft assembly extends.

In one embodiment, a catheter pump system is disclosed. The catheterpump system can include an impeller and a catheter body having a lumenin which fluid flows proximally therethrough during operation of thecatheter pump. The catheter pump system can include a drive shaftdisposed inside the catheter body and coupled with the impeller at adistal portion of the drive shaft, the drive shaft configured such thatrotation of the drive shaft causes the impeller to rotate. The catheterpump system can include a motor assembly. The motor assembly can includea chamber, at least a portion of the chamber in fluid communication withthe lumen of the catheter body. The motor assembly can also include arotor disposed in the at least a portion of the chamber, the rotormechanically coupled with a proximal portion of the drive shaft suchthat rotation of the rotor causes the drive shaft to rotate. The motorassembly can include a stator assembly disposed about the rotor andconfigured to cause the rotor to rotate. No cooling fins extend outsidean exterior surface of the motor assembly.

In another embodiment, a catheter pump system is disclosed. The catheterpump system can include an impeller and a catheter body having a lumentherethrough, the impeller mechanically coupled with a distal portion ofthe catheter body. The catheter pump system can include a guidewireguide tube disposed through the lumen from a proximal portion of thecatheter pump to a distal portion of the catheter pump, the guidewireguide tube configured to receive a guidewire therein. The catheter pumpsystem can include an end cap secured to a proximal end portion of theguide tube, the end cap configured such that axial movement of the endcap relative to the catheter body causes the guidewire guide tube to beremoved from the catheter pump. The catheter pump system can include aresealable closure device disposed at a proximal portion of the catheterpump, the closure device configured such that when the guidewire guidetube is removed from the catheter pump, the closure device encloses theproximal portion of the catheter pump system.

In another embodiment, a catheter pump system is disclosed. The catheterpump system can include a pump including an impeller for pumping blood.The catheter pump system can include a motor assembly for impartingrotation on the impeller through a drive shaft. The motor assembly cancomprise a stator carrying electrical windings and a rotor disposed inat least a portion of the stator, the rotor mechanically coupled with aproximal portion of the drive shaft. The catheter pump system caninclude a fluid supply system for delivering fluid to the pump duringoperation of the pump and returning at least some of the supplied fluidto a waste reservoir. The fluid supply system can comprise a fluidchannel extending within the stator and a fluid pathway which passesoutside the stator. During operation of the pump, at least a firstportion of the returning fluid can pass through the fluid channel and atleast a second portion of the returning fluid can pass through the fluidpathway.

In another embodiment, a method of operating a pump is disclosed. Thepump can comprise a motor which includes a stator assembly havingwindings and a rotor positioned within the stator assembly. The methodcan include rotating the rotor by selectively energizing the windings.The method can include cooling the motor by flowing a first fluidportion between the stator assembly and the rotor and by flowing asecond fluid portion outside the stator.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the subject matter of this applicationand the various advantages thereof can be realized by reference to thefollowing detailed description, in which reference is made to theaccompanying drawings in which:

FIG. 1A illustrates one embodiment of a catheter pump system with animpeller assembly configured for percutaneous application and operation.

FIG. 1B is a schematic view of one embodiment of a catheter pump systemadapted to be used in the manner illustrated in FIG. 1A.

FIG. 1C is a schematic view of another embodiment of a catheter pumpsystem.

FIG. 2 is a side plan view of a motor assembly of the catheter pumpsystem shown in FIG. 1B, according to various embodiments.

FIG. 3 is a perspective exploded view of the motor assembly shown inFIG. 2.

FIG. 4A is a side cross-sectional view of the motor assembly shown inFIGS. 2-3.

FIG. 4B is a side cross-sectional view of a motor assembly, according toanother embodiment.

FIG. 5 is a schematic perspective view of an interface between a distalchamber and a rotor chamber of a flow diverter of the motor assembly,with a stator assembly thereof hidden for ease of illustration.

FIG. 6A is a schematic perspective view of an interface between anoutput shaft of the motor assembly and a drive shaft of the catheterpump system.

FIG. 6B is a cross-sectional perspective view, taken through thelongitudinal axis of the catheter, showing the interface shown in FIG.6A.

FIG. 7 is an image of a cap and a female receiver, with the guide tubenot shown.

FIG. 8A is a schematic perspective view of a motor assembly, accordingto another embodiment.

FIG. 8B is a schematic perspective exploded view of the motor assemblyof FIG. 8A.

FIG. 8C is a schematic side view of the motor assembly of FIGS. 8A-8B.

FIG. 8D is a schematic side sectional, exploded view of the motorassembly shown in FIG. 8C.

FIG. 8E is a schematic side sectional view of the motor assembly shownin FIGS. 8A-8D.

FIG. 8F is a magnified schematic side sectional view of the motorassembly shown in FIG. 8E.

FIG. 8G is a schematic side sectional view of the seal shown in FIGS.8A-8F.

FIG. 9A is a schematic perspective view of a motor assembly, accordingto another embodiment.

FIG. 9B is a schematic side cross-sectional view of the motor assemblyof FIG. 9A.

More detailed descriptions of various embodiments of components forheart pumps useful to treat patients experiencing cardiac stress,including acute heart failure, are set forth below.

DETAILED DESCRIPTION

This application is generally directed to apparatuses for inducingmotion of a fluid relative to the apparatus. Exemplars of circulatorysupport systems for treating heart failure, and in particular emergentand/or acute heart failure, are disclosed in U.S. Pat. Nos. 4,625,712;4,686,982; 4,747,406; 4,895,557; 4,944,722; 6,176,848; 6,926,662;7,022,100; 7,393,181; 7,841,976; 8,157,719; 8,489,190; 8,597,170;8,721,517 and U.S. Pub. Nos. 2012/0178986 and 2014/0010686, the entirecontents of which patents and publications are incorporated by referencefor all purposes. In addition, this application incorporates byreference in its entirety and for all purposes the subject matterdisclosed in each of the following applications and the provisionalapplications to which they claim priority: application Ser. No.15/003,576, entitled “REDUCED ROTATIONAL MASS MOTOR ASSEMBLY FORCATHETER PUMP,” filed on Jan. 21, 2016, and claiming priority to U.S.Provisional Patent Application No. 62/106,670; application Ser. No.15/003,682, entitled “MOTOR ASSEMBLY WITH HEAT EXCHANGER FOR CATHETERPUMP,” filed on Jan. 21, 2016, and claiming priority to U.S. ProvisionalPatent Application No. 62/106,675; and application Ser. No. 15/003,696,entitled “ATTACHMENT MECHANISMS FOR MOTOR OF CATHETER PUMP,” filed onJan. 21, 2016, and claiming priority to U.S. Provisional PatentApplication No. 62/106,673.

In one example, an impeller can be coupled at a distal portion of theapparatus. In some embodiments, the motor is a brushless DC (BLDC)motor. In some embodiments, the motor is a micro BLDC motor. Someembodiments generally relate to various configurations for a motorassembly adapted to drive an impeller at a distal end of a catheterpump, e.g., a percutaneous heart pump. The motor described herein may beused for other applications including catheter-based devices like anatherectomy device. In such applications, the disclosed motor assemblyis disposed outside the patient in some embodiments. In otherembodiments, the disclosed motor assembly and/or features of the motorare miniaturized and sized to be inserted within the body, e.g., withinthe vasculature.

FIGS. 1A-1B show aspects of an exemplary catheter pump 100A that canprovide relatively high blood flow rates (i.e. full or near full bloodflow). As shown in FIG. 1B, the pump 100A includes a motor assembly 1driven by a console 122, which can include an electronic controller andvarious fluid handling systems. The console 122 directs the operation ofthe motor 1 and an infusion system that supplies a flow of fluid in thepump 100A. Additional details regarding the exemplary console 122 may beunderstood from U.S. Patent Publication No. US 2014/0275725, thecontents of which are incorporated by reference herein in their entiretyand for all purposes.

The pump 100A includes a catheter assembly 101 that can be coupled withthe motor assembly 1 and can house an impeller in an impeller assembly116A within a distal portion of the catheter assembly 101 of the pump100A. In various embodiments, the impeller is rotated remotely by themotor 1 when the pump 100A is operating. For example, the motor 1 can bedisposed outside the patient. In some embodiments, the motor 1 isseparate from the console 122, e.g., to be placed closer to the patient.In the exemplary system the pump is placed in the patient in a sterileenvironment and the console is outside the sterile environment. In oneembodiment, the motor is disposed on the sterile side of the system. Inother embodiments, the motor 1 is part of the console 122.

In still other embodiments, the motor 1 is miniaturized to be insertableinto the patient. For example, FIG. 1C is a schematic view of anotherembodiment of a catheter pump system. FIG. 1C is similar to FIG. 1B,except the motor 1 is miniaturized for insertion into the body. As shownin FIG. 1C, for example, the motor 1 can be disposed proximal theimpeller assembly 116A. The motor 1 can be generally similar to themotor assembly shown in FIG. 2, except the motor 1 is sized and shapedto be inserted into the patient's vasculature. One or more electricallines may extend from the motor to the console outside the patient. Theelectrical lines can send signals for controlling the operation of themotor. Such embodiments allow a drive shaft coupled with the impellerand disposed within the catheter assembly 101 to be much shorter, e.g.,shorter than the distance from the aortic valve to the aortic arch(about 5 cm or less). Various embodiments of the motor assembly 1 aredisclosed herein, including embodiments having a rotor disposed within astator assembly. In various embodiments, waste fluid can pass through ahousing in which the rotor is disposed to help cool the motor assembly1. In some embodiments, the housing in which the motor 1 of FIG. 1C isdisposed can be sealed from fluids (e.g., blood and/or saline) so as toisolate the electrical lines from the fluids. For example, as disclosedin the embodiments of FIGS. 8A-9B, one or more seals can be provided toimpede or prevent the flow of liquids into the housing.

FIG. 1A illustrates one use of the catheter pump 100A. A distal portionof the pump 100A including a catheter assembly including the impellerassembly 116A is placed in the left ventricle (LV) of the heart to pumpblood from the LV into the aorta. The pump 100A can be used in this wayto treat a wide range of heart failure patient populations including,but not limited to, cardiogenic shock (such as acute myocardialinfarction, acute decompensated heart failure, or postcardiotomy),myocarditis, and others. The pump can also be used for various otherindications including to support a patient during a cardiac inventionsuch as as a high-risk percutaneous coronary intervention (PCI) orablation. One convenient manner of placement of the distal portion ofthe pump 100A in the heart is by percutaneous access and delivery usinga modified Seldinger technique or other methods familiar tocardiologists. These approaches enable the pump 100A to be used inemergency medicine, a catheter lab and in other medical settings.Modifications can also enable the pump 100A to support the right side ofthe heart. Example modifications that could be used for right sidesupport include providing delivery features and/or shaping a distalportion that is to be placed through at least one heart valve from thevenous side, such as is discussed in U.S. Pat. Nos. 6,544,216;7,070,555; and US 2012-0203056A1, all of which are hereby incorporatedby reference herein in their entirety for all purposes.

The impeller assembly 116A (e.g., the impeller and cannula) can beexpandable and collapsible. In the collapsed state, the distal end ofthe catheter pump 100A can be advanced to the heart, for example,through an artery. In the expanded state the impeller assembly 116A isable to pump blood at relatively high flow rates. In particular, theexpandable cannula and impeller configuration allows for decoupling ofthe insertion size and flow rate, in other words, it allows for higherflow rates than would be possible through a lumen limited to theinsertion size with all other things being equal. In FIGS. 1A and 1B,the impeller assembly 116A is illustrated in the expanded state. Thecollapsed state can be provided by advancing a distal end 170A of anelongate body 174A distally over the impeller assembly 116A to cause theimpeller assembly 116A to collapse. This provides an outer profilethroughout the catheter assembly and catheter pump 100A that is of smalldiameter during insertion, for example, to a catheter size of about 12.5FR in various arrangements. In other embodiments, the impeller assembly116A is not expandable.

The mechanical components rotatably supporting the impeller within theimpeller assembly 116A permit relatively high rotational speeds whilecontrolling heat and particle generation that can come with high speeds.The infusion system delivers a cooling and lubricating solution to thedistal portion of the catheter pump 100A for these purposes. The spacefor delivery of this fluid is extremely limited. Some of the space isalso used for return of the fluid as waste fluid. Providing secureconnection and reliable routing of fluid into and out of the catheterpump 100A is critical and challenging in view of the small profile ofthe catheter assembly 101.

When activated, the catheter pump 100A can effectively support, restoreand/or increase the flow of blood out of the heart and through thepatient's vascular system. In various embodiments disclosed herein, thepump 100A can be configured to produce a maximum flow rate (e.g. zero mmHg backpressure) of greater than 4 Lpm, greater than 4.5 Lpm, greaterthan 5 Lpm, greater than 5.5 Lpm, greater than 6 Lpm, greater than 6.5Lpm, greater than 7 Lpm, greater than 7.5 Lpm, greater than 8 Lpm,greater than 9 Lpm, or greater than 10 Lpm. In various embodiments, thepump 100A can be configured to produce an average flow rate at 62 mmHgof greater than 2 Lpm, greater than 2.5 Lpm, greater than 3 Lpm, greaterthan 3.5 Lpm, greater than 4 Lpm, greater than 4.25 Lpm, greater than4.5 Lpm, greater than 5 Lpm, greater than 5.5 Lpm, greater than 6 Lpm,greater than 6.5 Lpm, greater than 7 Lpm, greater than 8 Lpm, or greaterthan 9 Lpm.

Various aspects of the pump and associated components can be combinedwith or substituted for those disclosed in U.S. Pat. Nos. 7,393,181;8,376,707; 7,841,976; 7,022,100; and 7,998,054, and in U.S. Pub. Nos.2011/0004046; 2012/0178986; 2012/0172655; 2012/0178985; and2012/0004495, the entire contents of each of which are incorporatedherein for all purposes by reference. In addition, various aspects ofthe pump and system can be combined with those disclosed in U.S. PatentPublication No. US 2013/0303970, entitled “DISTAL BEARING SUPPORT,”filed on Mar. 13, 2013; U.S. Patent Publication No. US 2014/0275725,entitled “FLUID HANDLING SYSTEM,” filed on Mar. 11, 2014; U.S. PatentPublication No. US 2013/0303969, entitled “SHEATH SYSTEM FOR CATHETERPUMP,” filed on Mar. 13, 2013; U.S. Patent Publication No. US2013/0303830, entitled “IMPELLER FOR CATHETER PUMP,” filed on Mar. 13,2013; U.S. Patent Publication No. US 2014/0012065, entitled “CATHETERPUMP,” filed on Mar. 13, 2013; and U.S. Patent Publication No. US2014/0010686, entitled “MOTOR ASSEMBLY FOR CATHETER PUMP,” filed on Mar.13, 2013, the entire contents of each of which are incorporated hereinfor all purposes by reference.

Moving from a distal end 1450 of the catheter assembly 101 of thecatheter pump 100A of FIG. 1B to a proximal end 1455, a primingapparatus 1400 can be disposed over the impeller assembly 116A. Asexplained above, the impeller assembly 116A can include an expandablecannula or housing and an impeller with one or more blades. As theimpeller rotates, blood can be pumped proximally (or distally in someimplementations) to function as a cardiac assist device.

In various embodiments, the pump is configured to be primed with fluid.Turning to FIG. 1B, a priming apparatus 1400 can be disposed over theimpeller assembly 116A near the distal end portion 170A of the elongatebody 174A. The priming apparatus 1400 can be used in connection with aprocedure to expel air from the impeller assembly 116A, e.g., any airthat is trapped within the housing or that remains within the elongatebody 174A near the distal end 170A. For example, the priming proceduremay be performed before the pump is inserted into the patient's vascularsystem, so that air bubbles are not allowed to enter and/or injure thepatient. The priming apparatus 1400 can include a primer housing 1401configured to be disposed around both the elongate body 174A and theimpeller assembly 116A. A sealing cap 1406 can be applied to theproximal end 1402 of the primer housing 1401 to substantially seal thepriming apparatus 1400 for priming, i.e., so that air does notproximally enter the elongate body 174A and also so that priming fluiddoes not flow out of the proximal end of the housing 1401. The sealingcap 1406 can couple to the primer housing 1401 in any way known to askilled artisan. In some embodiments, the sealing cap 1406 is threadedonto the primer housing by way of a threaded connector 1405 located atthe proximal end 1402 of the primer housing 1401. The sealing cap 1406can include a sealing recess disposed at the distal end of the sealingcap 1406. The sealing recess can be configured to allow the elongatebody 174A to pass through the sealing cap 1406.

The priming operation can proceed by introducing fluid into the sealedpriming apparatus 1400 to expel air from the impeller assembly 116A andthe elongate body 174A. Fluid can be introduced into the primingapparatus 1400 in a variety of ways. For example, fluid can beintroduced distally through the elongate body 174A into the primingapparatus 1400. In other embodiments, an inlet, such as a luer, canoptionally be formed on a side of the primer housing 1401 to allow forintroduction of fluid into the priming apparatus 1400. A gas permeablemembrane can be disposed on a distal end 1404 of the primer housing1401. The gas permeable membrane can permit air to escape from theprimer housing 1401 during priming.

The priming apparatus 1400 also can advantageously be configured tocollapse an expandable portion of the catheter pump 100A. The primerhousing 1401 can include a funnel 1415 where the inner diameter of thehousing decreases from distal to proximal. The funnel may be gentlycurved such that relative proximal movement of the impeller housingcauses the impeller housing to be collapsed by the funnel 1415. Duringor after the impeller housing has been fully collapsed, the distal end170A of the elongate body 174A can be moved distally relative to thecollapsed housing. After the impeller housing is fully collapsed andretracted into the elongate body 174A of the sheath assembly, thecatheter pump 100A can be removed from the priming apparatus 1400 beforea percutaneous heart procedure is performed, e.g., before the pump 100Ais activated to pump blood. The embodiments disclosed herein may beimplemented such that the total time for infusing the system isminimized or reduced. For example, in some implementations, the time tofully infuse the system can be about six minutes or less. In otherimplementations, the time to infuse can be about three minutes or less.In yet other implementations, the total time to infuse the system can beabout 45 seconds or less. It should be appreciated that lower times toinfuse can be advantageous for use with cardiovascular patients.Although the described pump is primed with fluid, one will appreciatefrom the description herein that the priming may be optional. Forexample, the pump can be prepared such that all air is removed before itis packaged. In another example, air is removed by placing the pumpunder vacuum.

With continued reference to FIG. 1B, the elongate body 174A extends fromthe impeller assembly 116A in a proximal direction to an fluid supplydevice 195. The fluid supply device 195 is configured to allow for fluidto enter the catheter assembly 101 of the catheter pump 100A and/or forwaste fluid to leave the catheter assembly 101 of the catheter pump100A. A catheter body 120A (which also passes through the elongate body174A) can extend proximally and couple to the motor assembly 1. Asdiscussed in more detail herein, the motor assembly 1 can provide torqueto a drive shaft that extends from the motor assembly 1 through thecatheter body 120A to couple to an impeller shaft at or proximal to theimpeller assembly 116A. The catheter body 120A can pass within theelongate body 174A such that the external elongate body 174A can axiallytranslate relative to the internal catheter body 120A.

Further, as shown in FIG. 1B, a fluid supply line 6 can fluidly couplewith the console 122 to supply saline or other fluid to the catheterpump 100A. The saline or other fluid can pass through an internal lumenof the internal catheter body 120A and can provide lubrication to theimpeller assembly 116A and/or chemicals to the patient. The suppliedfluid (e.g., saline, dextrose, glucose solution, or infusate) can besupplied to the patient by way of the catheter body 120A at any suitableflow rate. For example, in various embodiments, the fluid is supplied tothe patient at a flow rate in a range of 15 mL/hr to 50 mL/hr, or moreparticularly, in a range of 20 mL/hr to 40 mL/hr, or more particularly,in a range of 25 mL/hr to 35 mL/hr. One or more electrical conduits 124can provide electrical communication between the console 122 and themotor assembly 1. A controller within the console 122 can control theoperation of the motor assembly 1 during use.

Fluid (e.g., saline) can be provided from outside the patient (e.g., byway of one or more supply bags) to the pump through a supply lumen inthe catheter body. The fluid can return to the motor assembly 1 by wayof a lumen (e.g., a central or interior lumen) of the catheter body. Forexample, as explained herein, the fluid can return to the motor assembly1 through the same lumen in which the drive shaft is disposed. Inaddition, a waste line 7 can extend from the motor assembly 1 to a wastereservoir 126. Waste fluid from the catheter pump 100A can pass throughthe motor assembly 1 and out to the reservoir 126 by way of the wasteline 7. In various embodiments, the waste fluid flows to the motorassembly 1 and the reservoir 126 at a flow rate which is lower than thatat which the fluid is supplied to the patient. For example, some of thesupplied fluid may flow out of the catheter body 120A and into thepatient by way of one or more bearings. The waste fluid (e.g., a portionof the fluid which passes proximally back through the motor from thepatient) may flow through the motor assembly 1 at any suitable flowrate, e.g., at a flow rate in a range of 5 mL/hr to 20 mL/hr, or moreparticularly, in a range of 10 mL/hr to 15 mL/hr. Although described interms of fluid and waste lines, one will appreciate that the pump andmotor be configured to operate without fluid flushing. One purpose ofthe fluid supply is to cool the motor. In the case of a micromotordimensioned and configured to be inserted percutaneously, there may notbe a need for fluid cooling because the motor heat will be dissipated bythe body.

Access can be provided to a proximal end of the catheter assembly 101 ofthe catheter pump 100A prior to or during use. In one configuration, thecatheter assembly 101 is delivered over a guidewire 235. The guidewire235 may be conveniently extended through the entire length of thecatheter assembly 101 of the catheter pump 100A and out of a proximalend 1455 of the catheter assembly 101. In various embodiments, theconnection between the motor assembly 1 and the catheter assembly 101 isconfigured to be permanent, such that the catheter pump, the motorhousing and the motor are disposable components. However, in otherimplementations, the coupling between the motor housing and the catheterassembly 101 is disengageable, such that the motor and motor housing canbe decoupled from the catheter assembly 101 after use. In suchembodiments, the catheter assembly 101 distal of the motor can bedisposable, and the motor and motor housing can be re-usable.

In addition, FIG. 1B illustrates the guidewire 235 extending from aproximal guidewire opening 237 in the motor assembly 1. Before insertingthe catheter assembly 101 of the catheter pump 100A into a patient, aclinician may insert the guidewire 235 through the patient's vascularsystem to the heart to prepare a path for the impeller assembly 116A tothe heart. In some embodiments, the catheter pump 100A can include aguidewire guide tube 20 (see FIG. 3) passing through a central internallumen of the catheter pump 100A from the proximal guidewire opening 237.The guidewire guide tube 20 can be pre-installed in the catheter pump100A to provide the clinician with a preformed pathway along which toinsert the guidewire 235.

In one approach, the guidewire 235 is placed into a peripheral bloodvessel, and along the path between that blood vessel and the heart andinto a heart chamber, e.g., into the left ventricle. Thereafter, adistal end opening of the catheter pump 100A and guidewire guide tube 20can be advanced over the proximal end of the guidewire 235 to enabledelivery of the catheter pump 100A. After the proximal end of theguidewire 235 is urged proximally within the catheter pump 100A andemerges from the guidewire opening 237 and/or guidewire guide tube 20,the catheter pump 100A can be advanced into the patient. In one method,the guidewire guide tube 20 is withdrawn proximally while holding thecatheter pump 100A.

Alternatively, the clinician can insert the guidewire 235 through theproximal guidewire opening 237 and urge the guidewire 235 along theguidewire guide tube. The clinician can continue urging the guidewire235 through the patient's vascular system until the distal end of theguidewire 235 is positioned in the desired position, e.g., in a chamberof the patient's heart, a major blood vessel or other source of blood.As shown in FIG. 1B, a proximal end portion of the guidewire 235 canextend from the proximal guidewire opening 237. Once the distal end ofthe guidewire 235 is positioned in the heart, the clinician can maneuverthe impeller assembly 116A over the guidewire 235 until the impellerassembly 116A reaches the distal end of the guidewire 235 in the heart,blood vessel or other source of blood. The clinician can remove theguidewire 235 and the guidewire guide tube. The guidewire guide tube canalso be removed before or after the guidewire 235 is removed in someimplementations. After removing at least the guidewire 235, theclinician can activate the motor 1 to rotate the impeller and beginoperation of the pump 100A.

In yet another embodiment, catheter pump 100A is configured to beinserted using a modified Seldinger technique. The pump may beconfigured with a lumen therethrough for receiving a guidewire. Unlikethe embodiment described above, however, the guidewire is threadedthrough the pump without a guidewire guide tube. One will appreciatefrom the description herein that other configurations may be employedfor loading the pump onto a guidewire and/or moving the pump to thetarget location in the body. Examples of similar techniques aredescribed in U.S. Pat. No. 7,022,100 and U.S. Pub. No. 2005/0113631, theentire contents of which patent and publication are incorporated hereinfor all purposes.

FIGS. 2 and 3 further illustrate aspects of embodiments of the motorassembly 1 shown in FIG. 1B. The motor assembly 1 can include a statorassembly 2 (FIGS. 2-3) and a rotor 15 disposed radially within thestator assembly 2 (FIG. 3). The motor assembly 1 also includes a flowdiverter 3, which can be configured as a manifold for directing fluidthrough one or more passages in the catheter pump 100A. In some cases,the flow diverter 3 is at least partially disposed radially between thestator assembly 2 and the rotor 15 (FIGS. 2-3). The flow diverter 3 canbe fluidly sealed about the rotor 15 and a proximal portion 56 of thecatheter body 120A. The seal prevents leakage and also can prevent thefluid from contacting the stator assembly 2. The flow diverter 3 caninclude a distal chamber 5 within which the proximal portion 56 of thecatheter body 120A is disposed and a rotor chamber 4 within which therotor 15 is disposed. The distal chamber 5 is fluidly connected with thecatheter. The rotor chamber 4 is fluidly connected with the waste line7. The flow diverter 3 can also have a proximal chamber 10 in someembodiments. Where provided, the distal chamber 5, rotor chamber 4, andproximal chamber 10 can be in fluid communication within the flowdiverter 3. One or more flanges 11A, 11B can mechanically couple theflow diverter 3 to an external housing (not shown). The flanges 11A, 11Bare examples of mount structures that can be provided, which can includein various embodiments dampers to isolate the motor assembly 1 fromexternal shock or vibration. In some embodiments, mount structures caninclude dampers configured to isolate an outer housing or theenvironment external to the motor assembly 1 from shock or vibrationgenerated by the motor assembly 1. Further, an optional pressure sensorassembly 12 is configured to measure the pressure at a distal portion ofthe catheter pump 100A by, for example, measuring the pressure of acolumn of fluid that extends distally through a lumen of the catheterbody 120A. In addition, the guidewire guide tube 20 can extendproximally through the motor assembly 1 and can terminate at a tube endcap 8. As explained above, the guidewire 235 can be inserted within theguide tube 20 for guiding the catheter pump 100A to the heart.

In various embodiments, the rotor 15 and stator assembly 2 areconfigured as or are components of a frameless-style motor for drivingthe impeller assembly 116A at the distal end of the pump 100A. Forexample, the stator assembly 2 can comprise a stator and a plurality ofconductive windings producing a controlled magnetic field. The windingscan be wrapped about or in a stationary portion 65 of the statorassembly 2. The rotor 15 can comprise a magnetic material, e.g., caninclude one or more permanent magnets. In some embodiments, the rotor 15can comprise a multi-pole magnet, e.g., a four-pole or six-pole magnet.Providing changing electrical currents through the windings of thestator assembly 2 can create magnetic fields that interact with therotor 15 to cause the rotor 15 to rotate. This is commonly referred toas commutation. The console 122 can provide electrical power (e.g., 24V)to the stator assembly 2 to drive the motor assembly 1. One or moreleads 9 can electrically communicate with the stator assembly 2, e.g.,with one or more Hall sensors used to detect the speed and/or positionof the motor. In other embodiments, other sensors (e.g., opticalsensors) can be used to measure motor speed. The rotor 15 can be securedto an output shaft 13 (which can comprise a hollow shaft with a centrallumen) such that rotation of the rotor 15 causes the output shaft 13 torotate. In various embodiments, the motor assembly 1 can comprise adirect current (DC) brushless motor. In other embodiments, other typesof motors can be used, such as AC motors, gearhead motor, etc. As shownin FIG. 3, first and second journal bearings 18A, 18B can be providedabout the output shaft 13 to radially and/or longitudinally center theoutput shaft 13 and thereby the rotor 15 relative to the stator assembly2.

FIG. 4A shows that the output shaft 13 (which is secured to the rotor15) can be mechanically coupled with the proximal end portion of a driveshaft 16. The drive shaft 16 extends distally through an internal lumenof the catheter body 120A. A distal end portion of the drive shaft 16 ismechanically connected with the impeller. Thus, rotation of the rotor 15causes the output shaft 13 to rotate, which, in turn, causes the driveshaft 16 and the impeller to rotate. FIG. 4A also shows that a lumen 55can extend through the output shaft 13 and the rotor 15. In certainembodiments, the lumen 55 is coupled with a lumen of the catheter body120A such that the guidewire guide tube 20 can extend through the lumen55 within the rotor 15 and into the lumen of the catheter body 120A. Inaddition, the drive shaft 16 comprises a braided shaft having aninternal lumen. The braided drive shaft 16 or cable can be permeable toliquid such that supply fluid or waste fluid can flow from outside thedrive shaft 16 to within the internal lumen of the drive shaft 16 (andvice versa).

FIG. 4A shows the tube end cap 8 welded or otherwise secured to aproximal end portion of the guide tube 20. The cap 8 can be removablyengaged (e.g., screwed or otherwise removably locked) over a femalereceiver 71 that is secured in a proximal end of the proximal chamber10. For example, the proximal end of the female receiver 71 can bedisposed in a counterbore of the cap 8, while the guide tube 20 extendsthrough the central opening of the cap 8. In a locked configuration, oneor more tabs of the receiver 71 can be rotated such that the tab(s)slide under a corresponding tab in the counterbore of the cap 8. In anunlocked configuration, the tab(s) of the receiver 71 can be rotatedrelative to the tabs of the cap 8. FIG. 7 shows one embodiment of thecap 8 and of the female receiver 71 that can be coupled with the guidetube 20 (not shown). In the illustrated embodiment, the cap 8 can befixed to the guide tube 20; in other embodiments, the receiver 71 can befixed to the guide tube 20. Engaging the cap 8 to the receiver 71 canadvantageously prevent the guide tube 20 from accidentally being removedfrom or slid within the catheter pump 100A, e.g., if the patient orclinician impacts the cap 8. To remove the guide tube 20 (e.g., afterdelivery of the impeller assembly 116A to the heart), the clinician candisengage the cap 8 from the receiver 71 and can pull the guide tube 20from the catheter pump 100A, for example, by pulling proximally on theend cap 8. A resealable septum 72 (e.g., a resealable closure member)can be provided at the proximal end of the flow diverter 3, e.g., nearthe distal end of the cap 8 when the cap 8 is in place. When theguidewire guide tube 20 is removed from the pump 100A, the septum 72will naturally reseal the pathway proximally from the motor assembly 1such that fluid does not exit the assembly 1. An advantage of theassembly described herein is that the cap 8 is locked and will not bedislodged without rotating and unlocking cap 8 from receiver 71.Otherwise, the cap 8 can slide axially if it is inadvertently bumped bythe patient or clinician. This potentially results in the guide tube 20being pulled out from the distal-most end of the impeller assembly 116A,and because the guide tube cannot be re-inserted, the clinician eitherhas to use the catheter pump 100A without a guide or get a new pump.

With continued reference to FIG. 4A, it can be important to ensure thatthe motor assembly 1 is adequately cooled. In various embodiments, itcan be important to provide a heat removal system to limit buildup ofheat in the motor assembly 1 during operation. For example, it can beimportant to maintain external surfaces of the motor assembly 1 at atemperature less than about 40° C. if the motor assembly 1 is positionednear the patient. For example, an external surface of an externalhousing of the motor assembly 1 may be kept at or below thistemperature. In some respects, regulatory guidelines can require that nopart in contact with skin exceed 40° C. To that end, various strategiesfor heat management are employed by the inventions described herein. Itshould be appreciated that, as used herein, cooling refers totransferring away or dissipating heat, and in certain respects, coolingis used interchangeably with removing heat. In some embodiments,however, the fluids passing through or around the motor assembly 1 maynot be utilized for cooling purposes.

Various components of the motor assembly 1 generate heat. For example,moving parts within the motor assembly 1 (e.g., the rotating outputshaft 13 and/or drive shaft 16) can generate heat by virtue of lossesthrough friction, vibrations, and the like, which may increase theoverall temperature of the motor assembly 1. Further, heat can begenerated by the electrical current flowing through the stator assembly2 and/or by induction heating caused by conductive components inside arotating magnetic field. Furthermore, friction between the bearings 18A,18B and the output shaft 13 and/or friction between the drive shaft 16and the inner wall of catheter body 120A may also generate undesirableheat in the motor assembly. Inadequate cooling can result in temperatureincreases of the motor assembly 1, which can present patient discomfort,health risks, or performance losses. This can lead to undesirable usagelimitations and engineering complexity, for example, by requiringmitigation for differential heat expansion of adjacent components ofdifferent materials. Accordingly, various embodiments disclosed hereincan advantageously transfer away generated heat and cool the motorassembly 1 such that the operating temperature of the assembly 1 issufficiently low to avoid such complexities of use or operation and/orother components of the system. For example, various heat transfercomponents can be used to move heat away from thermal generation sourcesand away from the patient. Various aspects of the illustrated deviceherein are designed to reduce the risk of hot spots, reduce the risk ofheat spikes, and/or improve heat dissipation to the environment and awayfrom the patient.

In some embodiments, the catheter pump makes use of the fluid supplysystem already embedded in the pump to cool the motor assembly 1 andhousing. In some embodiments, heat absorbing capacity of fluid flowingthrough the flow diverter 3 is used to cool the motor assembly 1. Asshown in FIG. 4A, the supply line 6 can supply fluid 35 from a source(e.g., a fluid bag) to an outer lumen 57 of the catheter body 120A. Thesupplied fluid 35 can travel distally toward the impeller assembly 116Ato lubricate rotating components in the catheter assembly 101 and/orsupply fluid to the patient. A seal 19 (e.g., an o-ring) can be providedbetween the rotor chamber 4 and the distal chamber 5 to prevent backflowof the fluid 35 into the rotor chamber 4. In this context, backflow isflow of fluid 35 proximally into the distal chamber 5 rather thandistally within the lumen 57. Such flow is to be prevented to ensurethat the fluid 35 is initially exposed to moving parts in a distalportion of the catheter assembly 101 to lubricate and cool such distalcomponents.

Fluid from the catheter pump 100A can flow proximally through an innerlumen 58 of the catheter body 120A. For example, after initially coolingdistal components some or all of the supplied fluid 35 can flow withinthe drive shaft 16 and/or around the periphery of the drive shaft 16.After initially cooling distal components some or all of the suppliedfluid 35 can flow in a space disposed radially between the drive shaft16 and the catheter body 120A. The proximally-flowing fluid can flowalong a flow pathway which removes heat from the motor assembly 1. Asshown in FIG. 4A, the proximally-flowing fluid (or other cooling fluid)can flow into the rotor chamber 4 of the flow diverter 3. A firstportion 17A of the waste fluid can pass proximally through the motorassembly 1 about a periphery of the rotor 15, e.g., in a gap between therotor 15 and a wall of the flow diverter 3. In some embodiments, asecond portion 17B of the waste fluid can pass proximally through themotor assembly 1 through the lumen 55 of the output shaft 13. The fluidportions 17A, 17B can pass from the rotor chamber 4 into the proximalchamber 10 of the flow diverter 3, where the fluid 17A, 17B can flow outto a reservoir (not shown) by way of line 7.

The embodiment of FIG. 4A can advantageously convey heat from the heatgenerating components (e.g., rotor 15 and stator assembly 2) into thefluid 35 or other cooling fluid and to the reservoir 126 by way of thewaste line 7. For example, the first portion 17A of the fluid thatpasses about the periphery of the rotor 15 can direct heat radiallyoutward from the rotor 15 and other components of the flow diverter 3.The first portion 17A of the fluid that passes about the periphery ofthe rotor 15 can direct heat inward from the stator assembly 2 and othercomponents outside the flow diverter 3. The second portion 17B of thewaste fluid can draw heat radially inward, e.g., radially inward fromthe rotor 15 and other components of the flow diverter 3. As the heatfrom the motor assembly 1 is conveyed away by way of the fluid to thereservoir 126, the temperature of the motor housing can be reduced ormaintained at a suitable operational temperature for the medical staff,the patient and/or for the catheter pump system. A gap between thestator assembly and the external motor housing (e.g., the outer shell orhousing surrounding the motor assembly) comprises air (which has theadded benefit of being readily available and a good, natural insulator)or inert gas. Thus, the heat from the stator assembly 2 is naturallytransferred to the waste line rather than dissipating out the sides ofthe housing of the motor assembly 1.

FIG. 4B is a side cross-sectional view of a motor assembly 1, accordingto another embodiment. Unless otherwise noted, components numberedsimilar to those in FIG. 4A represent the same or similar components andfunctionalities. For example, as with the embodiment of FIG. 4A, in theembodiment of FIG. 4A, a first portion 17A of the fluid can passproximally through the motor assembly 1 about a periphery of the rotor15, e.g., in a gap between the rotor 15 and a wall of the flow diverter3. In some embodiments, a second portion 17B of the fluid can passproximally through the motor assembly 1 through the lumen 55 of theoutput shaft 13. The fluid portions 17A, 17B can pass from the rotorchamber 4 into the proximal chamber 10 of the flow diverter 3, where thefluid 17A, 17B can flow out to a reservoir (not shown) by way of line 7.Thus, the fluid portions 17A, 17B can flow along a first fluid pathwayor channel within the flow diverter 3 which is disposed inside thestator 2.

Unlike the embodiment of FIG. 4A, however, in the embodiment of FIG. 4B,a third portion 17C of the fluid can be shunted around the rotor 15 andstator assembly 2 along a second fluid pathway or channel. For example,as shown in FIG. 4B, the third portion 17C of the proximally-flowingfluid can be withdrawn from the inner lumen 58 of the catheter body 120Aby way of a suitable conduit and fluid connector. The third fluidportion 17C can bypass the motor assembly 1. The fluid can then beconveyed to the waste reservoir by a suitable waste line, which may bethe same as or different from the waste line 7. The third portion 17C ofthe proximally-flowing fluid can be more than, less than, or about thesame in volume as the combined volume of the first and second fluidportions 17A, 17B. In other embodiments, rather than being conveyeddirectly to a waste line, the third portion 17C can be transported by aconduit to a heat exchanger to further cool the motor assembly 1. Forexample, the third fluid portion 17C can be conveyed to coiled tubing ora tubular sleeve disposed about the stator assembly 2, as shown invarious embodiments of the following concurrently filed application:application Ser. No. 15/003,682, entitled “MOTOR ASSEMBLY WITH HEATEXCHANGER FOR CATHETER PUMP,” which is expressly incorporated byreference herein in its entirety and for all purposes.

The embodiment of FIG. 4B may be desirable in arrangements in which thefirst and second fluid portions 17A, 17B become too hot and/or otherwiseineffective at cooling the motor assembly 1. For example, in somearrangements, the motor assembly 1 may heat the first and second fluidportions 17A, 17B passing inside the flow diverter 3 to such a degreethat the temperatures of the fluid portions 17A, 17B and/or the motorassembly 1 rise to unacceptable levels. In such a situation, it may bedesirable to shunt some, most, or all of the proximally-flowing fluidaround the motor assembly 1 along the second fluid pathway. For example,in some embodiments, the first and second fluid portions 17A, 17B maypass through the flow diverter 3 along the first fluid pathway at a flowrate less than that provided in the embodiment of FIG. 4A. In theembodiment of FIG. 4A, the fluid may flow back proximally through theflow diverter at rate such that the combined flow rate of the first andsecond portions 17A, 17B is in a range of 5 mL/hr to 20 mL/hr, or moreparticularly, in a range of 10 mL/hr to 15 mL/hr.

In the embodiment of FIG. 4B, however, some, most, or all of theproximally-flowing fluid is diverted around the flow diverter 3 andother components of the motor along the second fluid pathway as thethird fluid portion 17C. The amount of the fluid portion 17C divertedaround the motor assembly 1 can be any suitable amount so as to maintainan adequate external temperature of the motor assembly 1. For example,in one embodiment, the third fluid portion 17C represents a relativelysmall volume of fluid diverted from the inner lumen 58. In oneembodiment, the third fluid portion 17C flows around the motor assembly1 at a flow rate in a range of 1 mL/hr to 30 mL/hr. In one embodiment,the third fluid portion 17C flows around the motor assembly 1 at a flowrate in a range of 1 mL/hr to 5 mL/hr, or in a range of 1 mL/hr to 3mL/hr. In one embodiment, the third fluid portion 17C flows around themotor assembly 1 at a flow rate in a range of 10 mL/hr to 50 mL/hr. Inanother embodiment, the third fluid portion 17C represents a majority ofthe fluid diverted from the inner lumen 58. For example, in such anembodiment, the third fluid portion 17C may have a flow rate in a rangeof 5.5 mL/hr to 12 mL/hr, in a range of 5.5 mL/hr to 10 mL/hr, in arange of 5.5 mL/hr to 8 mL/hr, in a range of 5.5 mL/hr to 7 mL/hr, in arange of 10 mL/hr to 14 mL/hr, or in a range of 8 mL/hr to 12 mL/hr.Advantageously, diverting some of the proximally-flowing fluid aroundthe motor assembly 1 can improve the transfer of heat away from themotor assembly 1, for example, in situations in which the first andsecond fluid portions 17A, 17B become too hot.

Moreover, in some embodiments, the console 122 can be configured tochange the amount of the third fluid portion 17C flowing along thesecond fluid pathway before and/or during a treatment procedure toadjust the volume of fluid that is diverted from the inner lumen 58around the motor assembly 1. For example, the console 122 can sendinstructions to a pump (such as a peristaltic pump) to adjust the flowrate of fluid shunted or bypassed around the motor assembly 1. Invarious respects, the terms “shunted” and “bypassed” are usedinterchangeably herein. In some embodiments, a common pump is applied toall three fluid portions 17A-17C. In other embodiments, one pump isapplied to draw the first and second fluid portions 17A, 17B, and aseparate pump is applied to draw the third fluid portion 17C.

In still other embodiments, all or substantially all the fluid flowingproximally through the inner lumen 58 is shunted around the motorassembly 1 along the second fluid pathway. The shunted third fluidportion 17C can be diverted to a waste reservoir and/or to a heatexchanger disposed about the stator assembly 2, as explained above. Insuch embodiments, all (100%) or substantially all (i.e., between 90% and100%) of the proximally-flowing fluid does not flow within the motorassembly 1 (e.g., within the flow diverter 3), but is instead divertedaround the motor assembly 1. Thus, in some embodiments, there may be noproximally-flowing fluid portions 17A, 17B within the flow diverter 3.In such arrangements, the motor assembly 1 may be adequately cooledwithout the fluid portions 17A, 17B flowing proximally through the flowdiverter 3. The fluid flowing proximally through the inner lumen 58 mayalso provide sufficient pressure so as to prevent air or other gasesfrom passing distally through the catheter body 120A to the patient.

Advantageously, the embodiments disclosed in FIGS. 1A-4B can adequatelyremove heat from the motor assembly 1 without requiring the use ofexternal cooling fins exposed to the outside environs. That is, thethermal performance of the heat removal systems disclosed in FIGS. 2-4Bcan adequately reduce the temperature of the outer surface of the motorhousing without using cooling fins exposed outside of the motor housing(e.g., outside of an exterior surface of the motor assembly 1) to theambient environment. Rather, the heat removal systems may be disposedentirely within the motor housing, e.g., within the housing whichencloses the rotor and stator. For example, in some embodiments, thesystems disclosed in FIGS. 1A-4B can ensure that the temperature of theexterior surface of the motor assembly 1 is not more than about 40° C.In some embodiments, the systems disclosed in FIGS. 1A-4B can ensurethat the temperature of the exterior surface of the motor assembly 1 isin a range of 15° C. to 42° C., or more particularly in a range of 20°C. to 42° C., in a range of 20° C. to 40° C., in a range of 20° C. to35° C., or in a range of 20° C. to 30° C., without requiring the use ofexternal cooling fins exposed outside the motor housing.

Still other thermal management techniques may be suitable in combinationwith the embodiments disclosed herein. For example, U.S. PatentPublication Nos. 2014/0031606 and 2011/0295345, which are incorporatedby reference herein in their entirety and for all purposes, describestructures and materials which may be incorporated in place of or inaddition to the devices described above to dissipate heat effectively,as will be understood by one of skill from the description herein. Forexample, in embodiments in which the motor is miniaturized so as to bedisposed within the patient's body, all or substantially all the fluidmay bypass or shunt around the motor. In such embodiments, theminiaturized motor may be sufficiently cooled by the flow of bloodpassing around the motor and/or motor housing.

FIG. 5 is a schematic perspective view of an interface between thedistal chamber 5 and the rotor chamber 4 of the flow diverter 3, withthe stator assembly 2 hidden for ease of illustration. FIG. 5 shows theoutput shaft 13 coupled with a proximal portion of the drive shaft 16through an aperture in the flange 11B. The journal bearings 18A (FIGS. 3and 5) and 18B (FIG. 3) can be provided on opposite axial sides of therotor 15 to help maintain the rotor 15 in radial alignment with therotor chamber 4 and/or in axial alignment with the stator assembly 2.Improving radial alignment of the rotor 15 and output shaft 13 relativeto the rotor chamber 4 can reduce or eliminate eccentricity duringrotation, which can reduce vibrations. Improving axial alignmentrelative to the stator assembly 2 can advantageously improve theefficiency of the motor assembly 1 by ensuring that the windings of thestator assembly 2 are adequately aligned with the rotor 15. In variousembodiments, the journal bearings 18A, 18B can be rotationally decoupledwith the output shaft 13 such that the output shaft 13 can rotaterelative to the bearings 18A, 18B. In some embodiments, the journalbearings 18A, 18B can be fixed inside the rotor chamber 4. Moreover, oneor more passages 59 can be provided through or across the bearings 18A,18B so that cooling fluid can pass axially through the bearings 18A,18B. For example, as shown in FIG. 5, the passages 59 are defined atleast in part by a cross-shaped structure of the bearings 18A, 18B, butother variations for the passages 59 may be suitable. For example, thebearings 18A, 18B can form radially-extending arms with one or more gapsdisposed between the arms. Such gaps can be enclosed peripherally by ahousing enclosing the stator assembly 2. In other embodiments, one ormore openings can be provided through the bearings 18A, 18B to definethe passages.

FIGS. 6A and 6B show one embodiment of an interface 22 between theoutput shaft 13 and the drive shaft 16. The interface 22 can comprise aconnection between a distal portion of the output shaft 13 and aproximal portion of the drive shaft 16. The distal portion of the outputshaft 13 can comprise a radially-inward taper and one or more holes 61formed through the output shaft 13. The proximal portion of the driveshaft 16 can be inserted within the lumen 55 of the output shaft 13 suchthat the lumen 55 and the inner lumen 58 of the catheter body 120A forma continuous passage. This passage can be used to advance the guidewireguide tube 20, sensors, and other instruments, or to provide fluidcommunication for cooling fluid or medications. Cooling fluid can flowproximally from the inner lumen 58 of the catheter body 120A and thefirst portion 17A of the fluid can pass outwardly about the periphery ofthe rotor 15. In some embodiments, the second portion 17B of the fluidcan pass through the lumen 55 of the output shaft 13. A sleeve 21 can bedisposed about the proximal portion of the catheter body 120A, and theseal 19 can be provided about the sleeve 21 to seal the distal chamber 5from the rotor chamber 4.

In the illustrated embodiments, the output shaft 13 is permanentlycoupled with, e.g., laser welded to the drive shaft 16. For example, awelding machine can access the interface 22 by way of the holes 61formed in the output shaft 13 to weld the output shaft 13 to the driveshaft 16. In other embodiments, the output shaft 13 can be secured tothe drive shaft 16 in other ways, e.g., by friction or interference fit,by adhesives, by mechanical fasteners, etc.

In some embodiments, the motor assembly 1 shown in FIGS. 1B-1C can besealed from the fluids (e.g., saline and/or bodily fluids) that passproximally through the catheter assembly. As explained herein, in someembodiments, the proximally-flowing fluid may flow from the catheterbody 120A through a chamber near the motor assembly 1. For example, inthe embodiments described above, the proximally-flowing fluid may flowthrough a chamber in which a portion of the motor assembly (e.g., therotor) is disposed, such as the flow diverter 3. For example, in someembodiments, the catheter pump system can include a shaft assembly 302and an impeller coupled with a distal portion of the shaft assembly 302.The catheter pump system can include a motor assembly 1 which impartsrotation on the impeller through the shaft assembly 302. The motorassembly 1 can comprise a motor 300 (e.g., an electric motor such as adirect drive electric motor) which rotates the shaft assembly 302. Insome embodiments disclosed herein, a direct drive motor can comprise amotor that lacks a gear reduction and/or a clutch. A fluid pathway canconvey fluid (e.g., waste fluid) proximally during operation of thecatheter pump system. In some arrangements, a seal 303 can be disposedbetween the motor assembly 1 and the impeller to impede or preventproximally-flowing fluids from entering the motor assembly 1 at leastabout an outer periphery 308 of the shaft assembly 302. In variousembodiments, the seal 303 can comprise an opening 309 through which aportion of the shaft assembly 302 extends. For example, in someembodiments, a lumen can comprise a motor lumen extending through atleast the motor 300. The lumen can pass through the catheter pump systemfrom a distal end of the catheter pump to a proximal end of the catheterpump system.

Turning to FIGS. 8A-8E, an example of a motor assembly 1 is disclosed,according to some embodiments. The motor assembly 1 of FIGS. 8A-8E maybe used in combination with any suitable features disclosed above inconnection with FIGS. 1A-7. Unless otherwise noted, like referencenumerals refer to components that are the same as or generally similarto the components shown in FIGS. 1A-7.

As shown in FIG. 8A, the motor assembly 1 can comprise a catheterassembly 101 comprising a catheter body 120A through which a drive shaft16 extends. As explained above, the drive shaft 16 can be disposedwithin an inner lumen 358 (see FIG. 8D) of the catheter body 120A. Thedrive shaft 16 can comprise a braided wire in various arrangements. Insome embodiments, the drive shaft 16 can be hollow, and fluids can flowtherethrough. In some embodiments, the drive shaft is formed of braidedwire which can be saturated with fluid. The catheter body 120A can becoupled with a chamber near or coupled with the motor assembly 1, suchas the flow diverter 3, by way of a retaining cap 301, which can securethe catheter body 120A to the chamber (e.g., flow diverter 3). The motorassembly 1 can comprise a motor 300. The motor 300 can comprise a directdrive electrical motor. The motor can be a direct current (DC) motor. Aswith the embodiments explained above, an end cap 8 and receiver 71 canbe provided at the proximal end of the motor assembly 1 to provideaccess to an internal lumen within the assembly 1. In variousembodiments, the end cap comprises a resealable material, e.g., toprovide resealable access for a guidewire guide tube and/or guidewire.It should be appreciated that although the flow diverter 3 isillustrated in FIG. 8A, however, any suitable type of chamber may bedisposed distal the motor assembly 1 to direct fluids into and/or out ofthe catheter assembly.

As shown in FIG. 8B, the flow diverter 3 can comprise a distal flowdiverter portion 3A and a proximal flow diverter portion 3B. Theretaining cap 301 can couple with the distal flow diverter portion 3Awith a washer 307 disposed therebetween. For example, the retaining cap301 and washer 307 can be disposed over the catheter body 120A. As shownin FIGS. 8B-8D, the flow diverter 3 can comprise a chamber in whichvarious components are disposed. For example, as shown in FIG. 8D, amotor coupling 305, a motor adapter 306, a gasket 304, and a seal 303can be disposed in the chamber of the flow diverter 3.

The motor coupling 305 can connect to a distal end portion of the motoroutput shaft 13, and can connect to a proximal portion of the motoradapter 306. In some arrangements, the motor coupling 305 can comprise afirst opening 311A sized and shaped to receive the proximal portion ofthe motor adapter 306 therein, and a second opening 311B sized andshaped to receive the distal end portion of the motor output shaft 13.In various embodiments, at least one of the openings 311A, 311B cancomprise a polygonal opening, e.g., a rectangular or square opening withat least one flat surface or edge. In the illustrated embodiment, thefirst opening 311A can comprise a polygonal opening, and the secondopening 311B can comprise a rounded opening. In other embodiments, thefirst opening 311A can comprise a rounded opening, and the secondopening 311B can comprise a polygonal opening. In FIG. 8D, the firstopening 311A can be fitted about the proximal end portion of the motoradapter 306, and the second opening 311B can be fitted about the distalend portion of the motor output shaft 13. The motor adapter 306 can bemechanically connected to the proximal end portion of the drive shaft16. The motor 300 can cause the output shaft 13 to rotate, which can inturn cause the motor coupling 305, motor adapter 306, and drive shaft 16to rotate to impart rotation on the impeller.

As explained above, fluids (such as saline) can flow proximally throughthe catheter pump system during operation of the impeller. For example,as shown in FIG. 8C, a supply fluid pathway 335 can direct fluid (e.g.,saline, infusate, etc.) distally through a lumen disposed within, but insome embodiments located off-center relative to a central longitudinalaxis of, the catheter body 120A to provide a lubricant, e.g., saline, tothe impeller. A return fluid pathway 317 can be provided along the innerlumen 358 of the catheter body 120A such that proximally flowing fluidflows towards the motor assembly 1 from a distal portion of the deviceadjacent to the impeller. The return fluid pathway 317 can flow withinand/or around the drive shaft 16, which can be disposed inside the innerlumen 358.

In various embodiments, it can be advantageous to prevent or impedefluids from entering the motor 300 and damaging or destroying sensitivecomponents within the motor 300. Accordingly, in the illustratedembodiment, the seal 303 and the gasket 304 can be disposed in thechamber of the flow diverter 3 to prevent or impede fluids from damagingsensitive components of the motor. In some embodiments, some or all ofthe fluid conveyed along the returning fluid pathway 317 exits the flowdiverter 3 by way of a first return pathway 317A. For example, the firstreturn pathway 317A can be in fluid communication with a waste line toconvey fluid flowing therein to and along the waste line (such as wasteline 7 described above) to a reservoir. The first return pathway 317Amay comprise a conduit that directs a portion of the fluid to bypass themotor assembly 1.

In some embodiments, some of the returning fluid (a second fluid pathway317B) can pass within the lumen 355 of the motor output shaft 13. Forexample, in such embodiments, the returning fluid 317 can flow throughthe inner lumen 358 of the catheter body 120A, which can fluidlycommunicate with the lumen 355 of the motor output shaft 13. Fluidconveyed in the returning fluid pathway 317 can flow proximally withinand/or around the drive shaft 16 (which can be disposed inside the innerlumen 358 of the catheter body 120A), through the motor adapter 306, themotor coupler 305, the seal 303, and the proximal flow diverter portion3B, and into the lumen 355 of the motor output shaft 13. In otherembodiments, no or little fluid may flow through the lumen 355 of theoutput shaft 13.

As shown in FIGS. 8C-8D, the shaft assembly 302 (e.g., including themotor output shaft 13) can extend through at least a portion of themotor 300, through the proximal flow diverter portion 3B, through anopening 309 of the seal 303, and into the motor coupling 305. The shaftassembly 302 (e.g., including the drive shaft 16) can further extendfrom the motor adapter 306 distally to the impeller assembly. Thus, inthe illustrated embodiment, the shaft assembly 302 and a lumen thereofcan extend through the seal 303.

As explained herein, a guidewire guide tube (not shown in FIGS. 8A-8E)may be disposed in a lumen which comprises the lumen 355 of the outputshaft 13 and the inner lumen 358 of the catheter body 120A. Theguidewire guide tube may extend through a lumen which extends betweenthe distal end of the catheter pump system and the proximal end of thecatheter pump system (i.e., proximally out the end cap 8). The clinicianmay insert a guidewire through the guidewire guide tube and may advancethe impeller assembly over the guidewire guide tube to a treatmentlocation, as explained above.

FIG. 8E is a schematic side sectional view of the motor assembly 1 shownin FIGS. 8A-8D. FIG. 8F is a magnified schematic side sectional view ofthe motor assembly shown in FIG. 8E. As explained above, the shaftassembly 302 may extend from the motor 300 into the chamber of the flowdiverter 3 through the opening 309 in the seal 303. The shaft assembly302 (which may comprise the drive shaft 16 and the motor output shaft13) may rotate relative to the proximal flow diverter portion 3B and theseal 303.

As shown in FIG. 8F, the seal 303 can comprise a lip seal having aflange 310 which extends towards and contacts the outer periphery 308 ofthe shaft assembly 302 (e.g., the output shaft 13 in some embodiments).The seal 303 can be disposed about the shaft assembly 302 and can bebiased radially inward to bear against the outer periphery 308 of theshaft assembly 302 to enhance the fluid sealing effect of the seal 303.For example, a biasing member 345 (e.g., a spring or other biasingmember such as a canted coil spring) may be disposed in the seal 303 tocause the flange 310 to bear against the outer periphery 308 of theshaft assembly 302. In various embodiments, the seal has a cupped orcanted shape. In some embodiments, the flange 310 can also define arecess into which some fluid being conveyed with the returning fluidpathway 317 can flow. The axial fluid flow component of the fluid thatis conveyed in the returning fluid pathway 317 (i.e., the component ofthe fluid which flows generally parallel to the shaft assembly 302) canpress against the flange 310 to convert the axial fluid forces (i.e.,the force of the proximally-flowing fluid along a direction parallel tothe shaft assembly 302) to radially inward pressure P to further bearagainst the outer periphery 308 of the shaft assembly 302.

In addition, in some embodiments, it can be advantageous to electricallyseparate or isolate the shaft assembly from the patient, for example, toreduce the risk of electrical shock from the motor. In such embodiments,an insulating coating can be provided over part or all of the shaftassembly 302 to electrically insulate the shaft assembly 302. Forexample, in some embodiments, a shaft assembly including the outputshaft 13 can be coated in an insulating material. In some embodiments, ashaft assembly including the drive shaft 16 can be coated in aninsulating material. In some embodiments, a shaft assembly including thedrive shaft 16 and the output shaft 13 can be coated in an insulatingmaterial. The insulating material which coats the shaft assembly 302 cancomprise any suitable insulator, such as polyimide.

FIG. 8G is a schematic side sectional view of the seal 303 shown inFIGS. 8A-8F. Unlike the arrangement shown in FIGS. 8A-8F, in FIG. 8G, asecond seal 303A (which may be similar to the seal 303) may be disposedadjacent and proximal the proximal flow diverter portion 3B, which mayact as a barrier between the motor 300 and the chamber (which may bedefined by the flow diverter in some arrangements). The second seal 303Amay also include an opening 309A through which a portion of the shaftassembly 302 may extend. The second seal 303A may be positioned betweenthe flow diverter portion 3B and the motor 300. As shown, the seal 303may be disposed adjacent and distal the proximal flow diverter portion3B. The second seal 303A may be positioned between the flow diverterportion 3B and a distal portion of the catheter body 120A. In variousarrangements, the proximal flow diverter portion 3B can act as a fluidbarrier between the motor assembly 1 and a majority of theproximally-flowing fluid. Although the second seal 303A is illustratedin FIG. 8G, in various arrangements, the second seal 303A may not beprovided. Thus, in FIG. 8G, the seal 303 may be disposed in the chamberof the flow diverter 3 (or other suitable structure which defines achamber), and the second seal 303A may be disposed outside the chamberof the flow diverter 3. As explained above, the shaft assembly 302 mayextend from the motor 300 into the chamber of the flow diverter 3through the opening 309 in the seal 303. The shaft assembly 302 (whichmay comprise the drive shaft 16 and the motor output shaft 13) mayrotate relative to the proximal flow diverter portion 3B and the seals303, 303A.

FIGS. 9A-9B illustrate another embodiment of a motor assembly 1 with aseal 303 that prevents or impedes proximally-flowing fluid from enteringthe motor assembly 1 at least about an outer periphery 308 of a shaftassembly 302. In the embodiment of FIGS. 9A-9B, the motor assembly 1 issimilar to the motor assembly 1 shown and described above in connectionwith FIGS. 2-7, except as noted herein. For example, the motor assemblyof FIGS. 9A-9B can comprise a rotor 15 disposed inside a rotor chamber4. A stator assembly 2 can be disposed outside the rotor chamber 4 aboutthe rotor 15 and rotor chamber 4. As explained above, the windings ofthe stator assembly 2 can be energized to cause the rotor 15 to rotate.Rotation of the rotor 15 can cause the output shaft 13 to impartrotation to the drive shaft 16 and the impeller at the distal portion ofthe system. Moreover, a flow diverter 3 can be disposed distal the motorassembly 1. As explained above, the flow diverter 3 can route fluiddistally to the impeller assembly and proximally to a waste reservoir.In the illustrated embodiment, the rotor 15, rotor chamber 4, and statorassembly 2 may be disposed proximal and outside the flow diverter 3.

Unlike the embodiments of FIGS. 2-7, all or a portion of the fluidflowing proximally through the catheter body 120A may be shunted aroundthe motor assembly 1, and the motor assembly 1 can be sealed such thatlittle or no fluid enters the motor assembly 1, e.g., little or no fluidenters the rotor chamber 4. For example, as with the embodiment of FIGS.8A-8G, a seal 303 can be provided between the rotor chamber 4 and theflow diverter 3 (which may act as a barrier between the rotor chamber 4and the proximally-flowing fluid. In various embodiments, the pumpsystem is configured to selectively shunt fluid around the motorassembly. The seal 303 used in connection with FIGS. 9A-9B can besimilar to the seals 303, 303A described in relation to FIGS. 8A-8G. Asexplained above, the seal 303 can be disposed about the shaft assembly302 and can be biased radially inward to bear against the outerperiphery 308 of the shaft assembly 302 to enhance the fluid sealingeffect of the seal 303. In addition, although one seal 303 isillustrated in FIG. 9B, it should be appreciated that a second seal(such as seal 303A) can be disposed opposite the barrier, e.g., on thedistal side of the barrier defined by the flow diverter 3.

Although the embodiments disclosed herein have been described withreference to particular embodiments, it is to be understood that theseembodiments are merely illustrative of the principles and applicationsof the present inventions. It is therefore to be understood thatnumerous modifications can be made to the illustrative embodiments andthat other arrangements can be devised without departing from the spiritand scope of the present inventions as defined by the appended claims.Thus, it is intended that the present application cover themodifications and variations of these embodiments and their equivalents.

What is claimed is:
 1. A catheter pump system comprising: a catheterassembly having a proximal end, a distal end, and an elongate bodyextending therebetween, the elongate body defining a central lumen; animpeller assembly configured translate axially relative to the elongatebody of the catheter assembly, the impeller assembly further configuredto be extended from the central lumen of the elongate body toward anextended position and retracted into the central lumen of the elongatebody toward a retracted position; and a priming apparatus including aprimer housing and a gas permeable membrane, wherein: the primer housingis configured to be disposed over the impeller assembly when theimpeller assembly is in the extended position, and the priming apparatusis configured to receive a liquid that causes a gas contained by theimpeller assembly to be expelled through the gas permeable membraneprior to insertion of the impeller assembly in a lumen of a human body.2. The catheter pump system of claim 1, wherein the priming apparatusfurther comprises a proximal end and a distal end, and wherein theproximal end of the priming apparatus is configured to receive and forma seal around at least a portion of the distal end of the elongate body.3. The catheter pump system of claim 2, wherein the priming apparatusfurther comprises a sealing cap disposed at the proximal end thereof,and wherein the sealing cap is configured to receive and form the sealaround at least the portion of the distal end of the elongate body. 4.The catheter pump system of claim 3, wherein the sealing cap includes arecess configured to receive and form the seal around at least theportion of the distal end of the elongate body.
 5. The catheter pumpsystem of claim 3, wherein the primer housing includes a funnel-shapedportion that tapers to a smaller diameter near the sealing cap.
 6. Thecatheter pump system of claim 5, wherein the funnel-shaped portion isconfigured to gradually compress the impeller assembly from a firstexpanded diameter in the extended position to a second retracteddiameter in the retracted position when the impeller assembly istranslated axially between the extended position and the retractedposition.
 7. The catheter pump system of claim 6, wherein the gaspermeable membrane is disposed substantially near a distal end of thepriming apparatus, whereby the gas contained by the impeller assembly isforced out of the gas permeable membrane when the impeller assembly iscompressed from the first expanded diameter to the second retracteddiameter as the impeller assembly is translated axially between theextended position and the retracted position.
 8. The catheter pumpsystem of claim 7, wherein the impeller assembly is configured toseparate from the priming apparatus when the impeller assembly is fullyretracted into the central lumen of the elongate body in the retractedposition.
 9. The catheter pump system of claim 1, wherein the primingapparatus is configured to receive the liquid through the central lumenof the elongate body of the catheter assembly.
 10. The catheter pumpsystem of claim 1, wherein the primer housing comprises an inlet, andwherein the priming apparatus is configured to receive the liquidthrough the inlet of the primer housing.
 11. A priming apparatus for usewith a catheter pump system, the priming apparatus comprising: a primerhousing having a distal end, a proximal end, and an elongate bodyextending therebetween; a sealing cap coupled to the proximal end of theprimer housing; and a gas permeable membrane, wherein: the primerhousing is configured to receive and enclose an impeller assembly whenthe impeller assembly is translated distally out of a central lumen of acatheter assembly; and in response to receiving the impeller assembly,the primer housing is further configured to receive a liquid that causesa gas contained by the impeller assembly to be expelled through the gaspermeable membrane prior to insertion of the impeller assembly in alumen of a human body.
 12. The priming apparatus of claim 11, whereinthe primer housing the proximal end of the primer housing is furtherconfigured to receive and form a seal around at least a portion of adistal end of the catheter assembly.
 13. The priming apparatus of claim12, wherein the sealing cap is configured to receive and form the sealaround at least the portion of the distal end of the catheter assembly.14. The priming apparatus of claim 13, wherein the sealing cap includesa recess configured to receive and form the seal around at least theportion of the distal end of the catheter assembly.
 15. The primingapparatus of claim 11, wherein the primer housing includes afunnel-shaped portion that tapers to a smaller diameter near the sealingcap.
 16. The priming apparatus of claim 15, wherein the funnel-shapedportion is configured to gradually compress the impeller assembly from afirst expanded diameter in an extended position to a second retracteddiameter in a retracted position, wherein, in the extended position, theimpeller assembly is at least partially outside the central lumen, andwherein, in the retracted position, the impeller assembly is at leastpartially within the central lumen.
 17. The priming apparatus of claim16, wherein the gas permeable membrane is disposed substantially near adistal end of the primer housing, whereby the gas contained by theimpeller assembly is forced out of the gas permeable membrane when theimpeller assembly is compressed from the first expanded diameter to thesecond retracted diameter.
 18. The priming apparatus of claim 11,wherein the priming apparatus is configured to receive the liquidthrough the central lumen of the catheter assembly.
 19. The primingapparatus of claim 11, wherein the primer housing comprises an inlet,and wherein the priming apparatus is configured to receive the liquidthrough the inlet of the primer housing.
 20. A method for removing airfrom an impeller assembly of a catheter pump system prior to insertionof the catheter pump system in a blood lumen of a human body, the methodcomprising: providing a priming apparatus including: a primer housinghaving a distal end, a proximal end, and an elongate body extendingtherebetween; a sealing cap coupled to the proximal end of the primerhousing; and a gas permeable membrane; inserting a distal end of acatheter assembly through the sealing cap of the priming apparatus;extending an impeller assembly contained within a central lumen of thecatheter assembly out of the central lumen into the primer housing;adding a liquid to the primer housing; and retracting the impellerassembly into the central lumen of the catheter assembly.